Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2024-06-30

Brief Summary

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Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.

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Detailed Description

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A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.

Conditions

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Subdeltoid Bursitis Injection Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention group

Dextrose injection, one time

Group Type EXPERIMENTAL

Dextrose

Intervention Type DRUG

Dextrose injection plus physical therapy

Control group

Normal saline injection, one time

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline injection plus physical therapy

Interventions

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Dextrose

Dextrose injection plus physical therapy

Intervention Type DRUG

Normal saline

Normal saline injection plus physical therapy

Intervention Type DRUG

Other Intervention Names

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physical therapy physical therapy

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up